Boehringer Ingelheim and PRIME enter a strategic collaboration Prime Vector Technologies (PRIME), a Biotech Startup focusing on the development of viral vector based vaccines, and Boehringer Ingelheim, a leading global research-based pharmaceutical company, announce that they have entered a strategic collabora- tion, option and licence agreement. The collaboration is set to establish and test up to eight dif- ferent vaccine candidates against a variety of veterinary diseases within the next three years us- ing PRIME’s proprietary Orf virus (ORFV) platform technology. ORFV platform ORFV belongs to the family of poxviridae and possesses an excellent safety profile, stable expression of multiple transgenes simultaneously and is well suited for the possibility of multiple dose immunizations. Prior to the collaboration agreement, the platform was de- veloped at the University of Tuebingen, and showed to be effective in various host ani- mals against different infectious diseases. “After so many years of research and devel- opment on our platform, we are proud to receive the commitment to and trust in our technology from Boehringer Ingelheim as one of the world’s leading pharmaceutical com- panies in the animal health market. With this strong partner, we are excited to advance our technology and to enhance our contribution to improving animal health,” says Dr. Ralf Amann, CEO of PRIME. About PRIME PRIME is an innovative, pre-clinical stage research and development company special- ized in designing next generation vaccines based on the ORFV vector platform. Using a modular brick system, the platform technology offers flexibility to generate multivalent and thus, highly effective vaccines. ORFV-based vaccines induce not only strong hu- moral, but also cellular immune responses and thus, are well suited for use as preventive, as well as therapeutic vaccines in humans and animals. The company was founded in 2019 as a spin-off from the University of Tuebingen in the frame of the EXIST high-tech startup support program from the federal ministry for economic affairs and energy. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that improve the lives of hu- mans and animals. As a leading research-driven biopharmaceutical company, the com- pany creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Hu- man Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. For more information on the Boehringer Ingelheim Animal Health business visit www.boehringer-ingelheim.com/animal-health Press Contact Dr. Ferdinand Salomon salomon@prime-vector-technologies.com T +49 7121 820 1642 Prime Vector Technologies GmbH Herrenberger Straße 24 D-72070 Tübingen www.prime-vector-technologies.com

Die Dr. Falk Pharma GmbH und Zedira geben den Start der klinischen Phase 2b-Studie mit ZED1227, einem direkt wirkenden und spezifischen Inhibitor der Gewebetransglutaminase (TG2), bei Patienten mit Zöliakie bekannt. Die sogenannte „real-life“ Studie verzichtet – im Gegensatz zur vorhergehenden Phase 2a Wirksamkeitsstudie - auf eine zusätzliche Glutenbelastung. Die Phase 2b-Studie schließt 400 Patienten in Europa ein, die trotz glutenfreier Diät Symptome und eine Schädigung der Dünndarmschleimhaut aufweisen.  Die Wirksamkeit, Sicherheit und Verträglichkeit von ZED1227 wurde bereits in früheren Studien gezeigt. Besonders ermutigend waren die Ergebnisse der Placebo-kontrollierten Phase 2a Studie: Jede der drei aktiven Dosisgruppen erreichte den primären Endpunkt. ZED1227 schwächte die Gluten-induzierte Schleimhautschädigung im Dünndarm ab. Im Vergleich zu Placebo schützten alle drei Dosierungen die Dünndarmschleimhaut signifikant besser vor Schädigung durch Glutenbelastung. Darüber hinaus verhinderte ZED1227 die Gluten-induzierte Entzündung, und die Patienten dokumentierten einen im Vergleich zu Placebo signifikant besseren Therapieerfolg in Bezug auf Symptome und Lebensqualität. Zudem wurde festgestellt, dass die oral verabreichte Medikation sicher und gut verträglich ist. Die Studienergebnisse wurden im Juli 2021 im New England Journal of Medicine publiziert [1]. Hintergrundinformationen zur Zöliakie: Zöliakie ist die häufigste chronische Entzündung des Dünndarms. Die Autoimmunerkrankung betrifft bis zu 2% der Bevölkerung und wird bei genetisch prädisponierten Personen durch Nahrungsgluten hervorgerufen. Ein wichtiger Schritt in der Pathogenese der Zöliakie ist die Gluten-Deamidierung und die immunogene Potenzierung, die durch die patienteneigene Gewebetransglutaminase im Darm verursacht wird. Das von Zedira entwickelte Molekül ZED1227 zielt auf die Gewebetransglutaminase im Dünndarm ab, um die Immunantwort auf Transglutaminase-modifiziertes Gluten zu verhindern, das den Krankheitsprozess antreibt. Die Hemmung der Gewebetransglutaminase hat das Potenzial, Patienten in Verbindung mit einer „weitgehend“ glutenfreien Ernährung zusätzliche Sicherheit zu bieten und damit die Lebensqualität von Millionen Menschen zu verbessern. Dr. Falk Pharma hat die Rechte für ZED1227 von dem auf Zöliakie und andere Transglutaminase-bedingte Erkrankungen spezialisierten Darmstädter Biotech-Unternehmen Zedira (www.zedira.com) für Europa lizenziert. Dr. Falk Pharma übernahm damit die Verantwortung für die präklinische und klinische Entwicklung dieses neuen pharmakologischen Wirkstoffs. Die frühe Phase der Entwicklung von ZED1227 wurde von einem gemeinsamen Forschungsprojekt von Zedira, Prof. Schuppan und der Dr. Falk Pharma GmbH im Rahmen des „Ci3-Cluster für individualisierte Immunintervention“ begleitet. Das Projekt wurde vom Bundesministerium für Bildung und Forschung finanziell unterstützt. Referenz: N Engl J Med 2021;385:35-45. DOI: 10.1056/NEJMoa2032441   Über Zedira GmbH: Das Darmstädter Unternehmen ist Spezialist für Erkrankungen, die mit Transglutaminasen in Zusammenhang stehen. Zedira produziert und vermarktet Spezialreagenzien für Forschung und Entwicklung sowie Diagnostika. Auf Basis selektiver Blocker von Transglutaminasen fokussiert sich das Unternehmen auf die frühen Phasen der Wirkstoffentwicklung. Leitindikation ist die Zöliakie. Mit ZED1227 hat das Unternehmen den ersten Transglutaminase-Inhibitor in die klinische Entwicklung gebracht. Die hier gewonnenen Erkenntnisse konnten in der Entwicklung eines neuartigen Antikoagulans (FXIIIa-Inhibitor) genutzt werden. Aktuell entwickelt das Unternehmen oral verfügbare Transglutaminase-Inhibitoren, die auf fibrotische Erkrankungen der Leber, Niere und Lunge abzielen. Zedira ist ein Portfolio-Unternehmen des High-Tech Gründerfonds. Über Dr. Falk Pharma GmbH: Die Dr. Falk Pharma GmbH mit Sitz in Freiburg entwickelt und vertreibt seit über 60 Jahren innovative Arzneimittel für verschiedene Erkrankungen der Leber, der Gallenwege, des Darms und der Speiseröhre. Als internationaler Spezialist für Verdauungs- und Stoffwechselmedizin bringt das Unternehmen Ärzte, Wissenschaftler und Patienten zusammen, um neue und wirkungsvolle Ansätze der Patientenversorgung zu entwickeln. Im Fokus der Forschungsinvestitionen und Studien ist das Ziel, die klinische Praxis und das Leben der Patienten nachhaltig zu verbessern. Das stetig wachsende Familienunternehmen mit globaler Vernetzung und 10 Tochtergesellschaften in Europa und Australien forscht und entwickelt in Freiburg. Hergestellt werden die pharmazeutischen Produkte in Europa, größtenteils in Deutschland, Frankreich und der Schweiz. Das mit der Region Breisgau tief verbundene Unternehmen beschäftigt 2021 rund 990 Mitarbeiter, davon 214 in Freiburg.

The highlight is a new end-to-end workflow that enables medtech companies and hospitals to manufacture products from high-performance polymers such as PEEK and bring them to market more quickly in accordance with FDA and MDR criteria. This November, Munich-based start-up Kumovis will be presenting new developments at AM Medical Days, COMPAMED and Formnext in Germany. In addition to the Kumovis R1 3D printer, which will manufacture implants live at the company's Formnext booth, panels and presentations are also part of the program. Munich, October 21, 2021 – Kumovis, the Munich-based medical 3D printing start-up, will show its new end-to-end workflow for the additive manufacturing of medical products this fall. With the industry-specific development, Kumovis enables medical devices made of high-performance polymers such as PEEK to be manufactured more efficiently than with conventional processes. What is more, manufacturers can bring these products to market in accordance with FDA and MDR criteria using the Kumovis workflow. Besides exhibiting the Kumovis R1 3D printer and medical applications at its booths, Kumovis will also be represented in panels and presentations at this year’s editions of COMPAMED, Formnext and AM Medical Days. AM Medical Days: Experience medtech future today The latter is the new decision-makers and experts conference on all things medical 3D printing at the Estrel Congress Center in Berlin. “As a founding partner of AM Medical Days, Kumovis is proud to be able to make another contribution to the future of 3D printing in medicine today,” says Stefan Leonhardt, co-CEO and co-founder of Kumovis. “Anyone who is professionally involved with 3D-printed medical devices or the future in the operating room shouldn’t miss this event.” Topics like these will be the focus of the panel discussion with Kumovis on the first day of the two-day conference. “Beyond AM Medical Days, we are looking forward to finally getting in touch with people in person again at the two must-attend events COMPAMED and Formnext,” Stefan Leonhardt adds. Furthermore, he will speak about the current state of 3D-printed polymer implants in his lecture at AM Medical Days: Which applications are possible today, which are still in the development phase? And how can innovations be implemented using 3D printing under more difficult market conditions – MDR is the catchword? Kumovis will answer these and other questions during AM Medical Days. From November 22 to 23, visitors will also find representative 3D-printed build parts made of medical-grade polymers at the Kumovis booth. Formnext: Additive manufacturing of implants live The Kumovis team will exhibit its new developments in Frankfurt too. At the start-up’s Formnext booth, Kumovis R1, the FLM 3D printer built for medical manufacturing, can be assessed live at an event for the first time since 2019. This year, Kumovis plans to 3D print implants on site so that every visitor will be able to convince themselves of the part quality. As at the other two events in November, visitors to the Kumovis booth at Formnext will learn everything about the new end-to-end workflow – from DICOM processing, 3D printing and post-processing to the approval of a medical device. On the one hand, the solution includes the provision of the 3D printer and slicing software; on the other hand, Kumovis provides application-specific processes and regulatory data such as machine qualification and biological and mechanical validation. With this complete package, medical device manufacturers can save costs and serve MDR and FDA markets compliantly and faster than with conventional processes such as milling or injection molding. Kumovis will be at Formnext from November 16 to 19 in hall 12.1, booth E29. COMPAMED: Approval is focus Medtech companies and hospitals achieve the familiar mechanical properties from conventional manufacturing when 3D printing medical products with Kumovis R1 and materials such as PEEK, PEKK or PPSU. Like visitors to Formnext, those at COMPAMED in Duesseldorf will be able to get their hands on 3D-printed parts at the Kumovis booth and see the parts’ quality for themselves from November 15 to 18. Application-specific products will be available at the Kumovis booth. And another medical technology concern is on the agenda: the new regulatory requirements of the MDR. Kumovis will address this topic in the “COMPAMED Suppliers Forum by DeviceMed” and give a presentation under the title “Implants and instruments individualized or mass-produced from high-performance polymers – design, 3D printing and approval”. The Kumovis medical and polymer technology experts will be available for further questions and discussions in hall 13, booth D32.   Brief overview of where to meet Kumovis COMPAMED starting November 15; hall 13, booth D32, Messe Duesseldorf Formnext starting November 16; hall 12.1, booth E29, Messe Frankfurt AM Medical Days starting November 22; booth 04, Estrel Congress Center Berlin   Media contact Stefan Killer Marketing & Communications Manager Phone: +49 89 61421614 Email: stefan.killer@kumovis.com   About Kumovis One thing up front: Kumovis is more than just another 3D printer manufacturer. Since its founding in 2017, the Munich-based start-up has been working on industry-specific end-to-end workflows to transform the manufacturing of medical devices and thus improve patient care. Kumovis has developed 3D printing technology specifically for this purpose and combined it with clean room technology. Be it in the industrial or surgical environment, the focus is on the economical production of functionalized as well as patient-matched implants and instruments made of high-performance polymers. Kumovis also provides medtech companies and hospitals with a regulatory roadmap and documentation, enabling new medical devices to benefit patients faster. For more information, please visit www.kumovis.com.